Enrotron 5 mg/ml orale oplossing voor varkens

Kraj: Holandia

Język: niderlandzki

Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Składnik aktywny:

ENROFLOXACINE

Dostępny od:

aniMedica GmbH

Kod ATC:

QJ01MA90

INN (International Nazwa):

ENROFLOXACINE

Forma farmaceutyczna:

Vloeistof voor oraal gebruik

Skład:

ENROFLOXACINE 5 mg/ml,

Droga podania:

Oraal gebruik

Typ recepty:

Uitsluitend door dierenartsen te gebruiken

Grupa terapeutyczna:

Varkens

Dziedzina terapeutyczna:

Enrofloxacin

Podsumowanie produktu:

Wachttermijn: Varkens Vlees 7 dagen

Status autoryzacji:

NL/V/0165/001

Data autoryzacji:

2013-03-19

Charakterystyka produktu

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 5 mg/ml oral solution for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
5.0 mg
EXCIPIENTS:
Benzyl alcohol (E-1519)
14.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (piglets)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the respiratory and alimentary tract caused
by enrofloxacin-sensitive
microorganisms. In particular:
•
Treatment of neonatal diarrhoea and septicaemia caused by
enrofloxacin-sensitive
_E. coli _
•
Treatment of respiratory infections caused by enrofloxacin-sensitive
_Pasteurella multocida_
,
_Mannheimia haemolytica_
and
_Mycoplasma _
spp.
•
Enzootic pneumonia
To be used where clinical experience and/or sensitivity testing
indicates enrofloxacin as the drug of
choice.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
other (fluoro)quinolones or to any of
the excipients.
Do not use in cases of disturbances to the growth of cartilage and/or
during injury to the locomotory
system, particularly if functionally loaded or body weight loaded
joints are affected.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when the product is used.
Do not use in case of confirmed or suspected resistance to quinolones,
since a high degree of cross
resistance between enrofloxacin and other quinolones does exist.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded
poorly, or are expected to respond poorly, to other classes of
antimicrobials.
Susceptibility testing should be performed before treatment is
initiated.
Use of the veterinary medicinal product deviating from instructions
given in the SPC may increase the
prevalence of bac